The Senate has sold
out the American people. Anyone voting for change in the last election
can now plainly see the shenanigans of a Democratic-controlled Senate.
Under Republicans no FDA reform ever took place. Big Pharma owns so many
Republicans that all meaningful legislation to curtail the deaths and
injuries of American citizens at the hands of Big Pharma and the FDA had
been completely thwarted for the past six years. Under Democratic control
sweeping FDA reform favorable to Big Pharma was proposed and the
majority of meaningful reform was blocked or seriously watered down. Which
is worse? As Kennedy stated in his opening remarks today, S1082 (the Kennedy/Enzi
FDA bill) was an “elaborate scheme.”

The final passage
of S1082 was never in doubt (final vote was 93-1). In fact, Kennedy and
Enzi gave Big Pharma a 40 yard head start in a 100 yard dash; it wasn’t
much of a contest. Their legislation perpetuated the user fees allowing
Big Pharma to buy mob-like protection from the FDA. The bill created the
Reagan-Udall Foundation for the FDA to hold FDA-related patents and allowed
the FDA to license technology to drug companies – thus turning the FDA
into a drug company with vested interests in specific medicines. None
of these blatant conflicts of interest, which are also primary safety
issues, seemed to bother any senators at all.

Hypocrisy Gone
Wild

The bill claimed
to be a safety bill and all arguments from either side on any issue were
always presented as safety related. Thus, every Senator was using the
same set of words to describe both sides of the issue. Each side claimed
the other was using the safety term hypocritically, resulting in a bewildering
debate. All of this was staged to confuse the public and perpetuate a
myth that safety legislation was being meaningfully debated.

What was really being
debated was the extent to which the Big Pharma monopoly would be allowed
to continue, an issue that was too politically incorrect to describe publicly.
The debate was actually about how sharply Big Pharma’s exorbitant profits
and reckless behavior would be curtailed compared to how many Americans
would be exposed to injury and death at the hands of Big Pharma.

Earlier in the week
a fight broke out between a contingent of Democrats lead by Senator Kennedy
(D-MA) and a larger contingent lead by Byron Dorgan (D-ND). However, when
the Kennedy clan joined the Republicans their odd Big Pharma-sponsored
coalition held an advantage. This group of Senators undermined the free
market and perpetuated the high cost of drugs in this country compared
to all others countries – a 50 billion dollar gift to Big Pharma.

Double talk became
the order of the day. On the one hand it was funny to watch, as Democrats
attacked each other. On the other hand it was sad to watch, as this pathetic
debate will result in window-dressing reform, with enough Big Pharma loopholes
to drive a Mack Truck through. Attempts by well meaning senators to correct
flagrant flaws in the legislation were either watered down to the point
of nonsense or blocked entirely.

Many key issues were
not addressed, such as the FDA’s legal position to prevent citizens from
suing drug companies, the massive (and oftentimes illegal) off label promotion
of drugs by the legion of Big Pharma sales reps, medical journals that
are full of fraudulent Big Pharma promo pieces that misrepresent the safety
and efficacy of drugs currently on the market, and a large percentage
of doctors on the take from Big Pharma.

Big Pharma Wins
Key Amendment Votes

On the final day
it all boiled down to two keys votes. One vote was on the Grassley amendment
#1039 which would have given true power to scientists in the FDA responsible
for regulating the safety of drugs already on the market. The FDA and
Big Pharma were adamantly opposed to this amendment. The vote was Big
Pharma 47 – Americans 46, defeating the amendment. This vote was not only
a sell out of Dr. David Graham and other FDA scientists who have gone
to Congress as whistleblowers to save American lives, it was an “acid-test”
vote on who is truly on Big Pharma’s payroll. Click
here to see how your senators voted.

The other key vote
came on the Durbin amendment #1034. This amendment sought to prevent Big
Pharma from placing “experts” on FDA Advisory Committees – which make
the final decisions on the safety of drugs. Durbin argued the obvious
point that hundreds of millions of dollars are at stake as well as the
lives of Americans and that such flagrant conflicts of interest must be
stopped. He pointed out that the FDA Advisory Committee that ruled on
the safety of Vioxx had 10 “experts” on the Big Pharma bankroll, resulting
in over 50,000 deaths. Kennedy and Enzi argued that these conflicts of
interest were necessary and a fact of life and needed for science to progress???
The vote was Big Pharma 47 – Americans 47, and in this case the tie went
to Big Pharma and the amendment was defeated. Click
here to see how your senators voted.

Two-faced senators
threw a dog bone to those promoting safety, as a second Grassley amendment
that called for stiffer civil penalties against Big Pharma wrongdoing
was approved.

The Senate has punted
when given a major opportunity to protect the health and well being of
Americans. S1082 is the best “safety” legislation that Big Pharma money
could buy.

The Voice of Health
Freedom was Heard

Many thousands of
Americans flooded the Senate with objections to a clause relating to the
Reagan-Udall Foundation for the FDA, which could be used to target dietary
supplements by evaluating them as drugs for safety purposes. While Enzi
refused to change the language, we created such an uproar that assurances
are officially in the Congressional Record that this legislation is not
to be used to harass dietary supplements.

And we headed off
a potential attack by Durbin – who for some reason is always trying to
get vitamins classified as drugs (more safety hypocrisy). Key to this
effort was myself writing for NewsWithViews.com, Mike Adams writing for
NewsTarget.com, and John Hammell of the International Advocates for Health
Freedom. Support also came from many other groups who forwarded the message.
All of our efforts resulted in the following testimony on the floor of
the Senate as reported in the Congressional Record.

May 2, 2007:

Mr. HATCH. My office
has been inundated by calls from people throughout the country who believe
that this legislation, specifically the provision establishing a Reagan-Udall
Institute, will overturn the Dietary Supplement Health and Education Act
of 1994. That has not been my reading of the bill, but I wonder if other
Senators have heard similar concerns?

Mr. HARKIN. Yes,
I have received a good many calls as well. And, I have to say that I would
be very concerned, as I know the Senator from Utah is, if anything in
the bill we are considering, S.1082, would overturn DSHEA, a law we fought
side-by-side to see enacted.

Mr. ENZI. It might
be helpful if I explained the provision you are discussing, as my office
has received many calls as well and I believe the callers are not informed
about this matter. Subtitle B of title II of S. 1028 establishes the Reagan-Udall
Foundation for the Food and Drug Administration. That simple purpose of
that nonprofit Foundation is to lead collaborations among the FDA, academic
research institutions and industry designed to bolster research and development
productivity, provide new tools for improving safety in regulated product
evaluation, and in the long term make the development of those products
more predictable and manageable.

Mr. KENNEDY. That
is exactly the purpose of the Foundation, which was included in the drug
safety legislation Senator Enzi and I introduced last year. The
Foundation will be financially supported by industry and philanthropic
donated funds. A chief scientist at FDA will promote intramural research
and coordinate it with efforts at the Foundation.

Mr. HATCH. That explanation
is very helpful. What, specifically, would the role of the Foundation
be with respect to dietary supplements?

Mr. KENNEDY. Let
me make absolutely clear that the Reagan-Udall Foundation will in no way
override, overturn or conflict with the Dietary Supplement Health and
Education Act. Nothing in this bill would have that effect.

Mr. ENZI. Yes, we
took great pains to make certain there would be no conflict with DSHEA.
Regarding foods, and dietary supplements are generally regulated as foods,
the general directive of the Foundation is to identify holes in the evaluation
of food safety and identify ways to address those deficiencies through
collaborative research with industry.

Mr. HARKIN. So to
make this absolutely clear, what you are saying is that the bill we are
debating would in no way interfere with consumers' access to dietary supplements?

Mr. HATCH. To add
to that point, it seems that the language could, in fact, help dietary
supplement consumers, because it would allow collaboration between government
and industry to conduct research on issues that might be helpful to supplement
consumers?

Mr. KENNEDY. Yes,
that is the case.

Mr. ENZI. I agree
with Chairman Kennedy's assessment.

Mr. HATCH. I thank
you for those assurances and that clarification.

Mr. HARKIN. This
has been a very helpful discussion, because Senator Hatch and I could
never support legislation that would interfere with DSHEA and we are glad
to receive the assurances of the chairman and the ranking Republican on
the committee.

On May 1 we sent
out another urgent call to action because Durbin was planning an end run
around DSHEA that would further attack dietary supplements. Once again
the people flooded the Senate and on May, 3, 2007, Senator Hatch responded
to the concerns we raised. The Congressional Record states:

Mr. HATCH. Mr. President,
a number of questions have been raised about how the Durbin amendment
on food safety, adopted yesterday by a unanimous vote, would affect regulation
of dietary supplements….

For the edification
of my colleagues, section 201ff of the Federal Food, Drug and Cosmetic
Act, FFDCA, contains the definition of dietary supplements. That definition
includes a proviso that supplements are to be considered foods, except
in the instance when a product makes a drug claim. In other words, by
Federal law, dietary supplements are generally considered to be foods.

It is for this reason
that the language of the original Durbin amendment establishing a new
adulterated food registry could have been read to apply to dietary supplements.

This raised problems
for me, and indeed for our colleague Senator Harkin, since we had spent
more than 2 years working with Senators Durbin, Kennedy, and Enzi
to draft, pass and enact the Dietary Supplement and Nonprescription Drug
Consumer Protection Act, Public Law 109-462. That law authorizes a new
program so that reports of serious adverse events related to the use of
a dietary supplement or over-the-counter drug would be reported to the
Food and Drug Administration, FDA, on a priority basis.

As I said, the Durbin
amendment contemplates a new adulterated food registry. Under the provisions
establishing that registry, reports of adulterated foods would be made
by many, if not all, of the same parties who are required to file reports
of serious adverse events associated with the use of dietary supplements
under Public Law 109-462. And so passage of the Durbin amendment could
be seen to supersede the law we enacted last year for supplements, which
I am relieved to hear was not the intent of our colleague, Senator Durbin.

Consequently, the
amendment we adopted yesterday contains language that Senator Harkin
and I suggested to make certain that dietary supplements would not be
covered by the new food safety language and thus last year's law would
not be superseded. To reassure those who are interested in the Dietary
Supplement Health and Education Act, DSHEA, I wanted to take a moment
to outline those changes.

First, there is new
language in the section establishing the adulterated food registry to
express the sense of the Senate that: (1) DSHEA has established the legal
framework to ensure that dietary supplements are safe and properly labeled
foods; (2) the Dietary Supplement and Nonprescription Drug Consumer Protection
Act has established a mandatory reporting system of serious adverse events
for nonprescription drugs and dietary supplements sold and consumed in
the United States; and (3) the adverse events reporting system under that
act will serve as the early warning system for any potential public health
issues associated with the use of these food products.

In addition, language
contained in the Durbin amendment modifies the definition of supplement
contained in 201ff of the FFDCA so that supplements will not be considered
foods for the purpose of the new adulterated foods registry. This in no
way would alter the time-honored conclusion of the Congress that supplements
are to be considered foods. On the contrary, all it would do is exempt
supplements from the registry.

These changes, all
contained in the amendment which was approved yesterday, make clear that
there are no new dietary supplement requirements in the Food and Drug
Administration Revitalization Act. It is my hope this will reassure the
many who have expressed concern that Congress was inadvertently repealing
Public Law 109-462.

The voice of the
people has been heard. Let us not forget these promises nor let the FDA
forget them – as the questionable language regarding the Reagan-Udall
Foundation for the FDA still remains.

Waking up the American
public to the larger issue of drug safety is a much more challenging task.
Kennedy and Enzi are claiming that the Reagan-Udall Foundation for the
FDA is nothing but a friendly non-governmental research foundation. I
will fully document in a subsequent article that this is not the case.
It is actually the tool by which Big Pharma and Big Biotech will lock
in their profits for the next 50 years, as FDA joins them in the drug
development and marketing business. This is one of the greatest safety
threats in the history of America.

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The battle now moves
to the House and then to a conference committee. The legislation is being
ramrodded through before the general public knows what is happening. Mainstream
media, a primary client of Big Pharma, is intentionally failing to explain
the true meaning of S1082. There is still time for Americans to determine
their fate.

Richards encourages
individuals to take charge of their health, stand up for their health
rights, and not blindly succumb to propaganda from the vested-interests
who profit from keeping Americans sick. As founder of Wellness Resources,
Inc. of Minneapolis, MN, an independently-owned fine-quality dietary supplement
company since 1985, he has personally developed 75 unique nutraceutical-grade
nutritional formulas. www.wellnessresources.com